Drugs@FDA: FDA Approved Drug Products

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Biologic License Application (BLA): 125249
Company: REGENERON PHARMACEUTICALS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ARCALYST RILONACEPT 220MG VIAL; SINGLE-USE Prescription None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/27/2008 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125249s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/125249s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/30/2010 SUPPL-18 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/27/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf

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